Person who experienced the adverse event (patient)
| Event ID | CASEID | CASEVERSION | I F COD | EVENT DT | MFR DT | INIT FDA DT | FDA DT | REPT COD | AUTH NUM | MFR NUM | MFR SNDR | LIT REF | AGE | AGE COD | AGE GRP | GNDR COD | E SUB | WT | WT COD | REPT DT | TO MFR | OCCP COD | REPORTER COUNTRY | OCCR COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125862481 | 12586248 | 1 | I | 200712 | 20160204 | 20160725 | 20160725 | PER | US-JAZZ-2016-US-002139 | JAZZ | 42.06 | YR | F | Y | 0.00000 | 20160725 | US | US |
Drug(s) used by person
| Event ID | CASEID | DRUG SEQ | ROLE COD | DRUGNAME | PROD AI | VAL VBM | ROUTE | DOSE VBM | CUM DOSE CHR | CUM DOSE UNIT | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM | DOSE AMT | DOSE UNIT | DOSE FORM | DOSE FREQ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125862481 | 12586248 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 125862481 | 12586248 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 125862481 | 12586248 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4 G, BID | 21196 | 4 | G | ORAL SOLUTION | |||||||
| 125862481 | 12586248 | 4 | SS | PROVIGIL | MODAFINIL | 1 | UNKNOWN DOSE | Y | 0 | ||||||||||
| 125862481 | 12586248 | 5 | C | FLURBIPROFEN. | FLURBIPROFEN | 1 | UNK | U | 0 | ||||||||||
| 125862481 | 12586248 | 6 | C | FLEXERIL | CYCLOBENZAPRINE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 125862481 | 12586248 | 7 | C | GABAPENTIN. | GABAPENTIN | 1 | UNK | U | 0 | ||||||||||
| 125862481 | 12586248 | 8 | C | LIDOCAINE. | LIDOCAINE | 1 | UNK | U | 0 | ||||||||||
| 125862481 | 12586248 | 9 | C | ARMOUR THYROID | THYROID, PORCINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125862481 | 12586248 | 10 | C | HYDROCHLOROTHIAZIDE. | HYDROCHLOROTHIAZIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125862481 | 12586248 | 11 | C | MEDROL | METHYLPREDNISOLONE | 1 | UNK | U | 0 | ||||||||||
| 125862481 | 12586248 | 12 | C | PRAVASTATIN SODIUM. | PRAVASTATIN SODIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 125862481 | 12586248 | 13 | C | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125862481 | 12586248 | 14 | C | NUVIGIL | ARMODAFINIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 125862481 | 12586248 | 15 | C | RITALIN | METHYLPHENIDATE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125862481 | 12586248 | 16 | C | ZOLOFT | SERTRALINE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 125862481 | 12586248 | 17 | C | DOXYCYCLINE. | DOXYCYCLINE | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125862481 | 12586248 | 1 | Narcolepsy |
| 125862481 | 12586248 | 2 | Cataplexy |
| 125862481 | 12586248 | 4 | Product used for unknown indication |
| 125862481 | 12586248 | 5 | Product used for unknown indication |
| 125862481 | 12586248 | 6 | Product used for unknown indication |
| 125862481 | 12586248 | 7 | Product used for unknown indication |
| 125862481 | 12586248 | 8 | Product used for unknown indication |
| 125862481 | 12586248 | 9 | Product used for unknown indication |
| 125862481 | 12586248 | 10 | Product used for unknown indication |
| 125862481 | 12586248 | 11 | Product used for unknown indication |
| 125862481 | 12586248 | 12 | Product used for unknown indication |
| 125862481 | 12586248 | 13 | Product used for unknown indication |
| 125862481 | 12586248 | 14 | Product used for unknown indication |
| 125862481 | 12586248 | 15 | Product used for unknown indication |
| 125862481 | 12586248 | 16 | Product used for unknown indication |
| 125862481 | 12586248 | 17 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125862481 | 12586248 | Acne | |
| 125862481 | 12586248 | Blood pressure increased | |
| 125862481 | 12586248 | Cataplexy | |
| 125862481 | 12586248 | Dizziness | |
| 125862481 | 12586248 | Dyspnoea | |
| 125862481 | 12586248 | Eczema | |
| 125862481 | 12586248 | Headache | |
| 125862481 | 12586248 | Muscle spasms | |
| 125862481 | 12586248 | Tinnitus |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 125862481 | 12586248 | 1 | 200712 | 201103 | 0 | |
| 125862481 | 12586248 | 3 | 201510 | 0 | ||
| 125862481 | 12586248 | 5 | 20160130 | 0 | ||
| 125862481 | 12586248 | 6 | 20160130 | 0 | ||
| 125862481 | 12586248 | 7 | 20160130 | 0 | ||
| 125862481 | 12586248 | 8 | 20160130 | 0 | ||
| 125862481 | 12586248 | 9 | 20151002 | 0 | ||
| 125862481 | 12586248 | 10 | 20150923 | 0 | ||
| 125862481 | 12586248 | 11 | 20150923 | 20150930 | 0 | |
| 125862481 | 12586248 | 12 | 20150923 | 0 | ||
| 125862481 | 12586248 | 13 | 20150923 | 0 | ||
| 125862481 | 12586248 | 14 | 20150909 | 0 | ||
| 125862481 | 12586248 | 15 | 20150506 | 20150506 | 0 | |
| 125862481 | 12586248 | 16 | 20150101 | 20151002 | 0 | |
| 125862481 | 12586248 | 17 | 20140101 | 20141230 | 0 |